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临床试验/NCT03054675
NCT03054675已完成不适用

Perioperative Lung Function Monitoring After Anatomic Lung Resections

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
328
试验地点
1
主要终点
Decrease in FEV1

研究概览

简要总结

Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches.

详细描述

All patients undergoing an anatomical lung resection at the investigators' institution were evaluated for this study. Underage patients and those undergoing extended resections (including resection of the chest wall and/or diaphragm) and/or bronchoplastic procedures were excluded.

In every eligible patient undergoing an anatomic lung resection, preoperative spirometry was performed using a handheld spirometer on the day before surgery and on every second day after surgery was performed until patient discharge. The absolute values of FEV1 were recorded by an independent study nurse and noted on a separate sheet not available to the treating doctors.

At the end of the study period FEV1 values were evaluated especially with focus on their correlation with postoperative pulmonary complications (i.e. pneumonia, acute exacerbation of COPD, air leak and atelectasis). Furthermore lung function values of patients undergoing 'open' resections were compared with patients undergoing minimally invasive resections.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing anatomical lung resection
  • Written informed consent

排除标准

  • Underage patients
  • Extended resections including resection of chest wall or diaphragm
  • Bronchoplastic resections

结局指标

主要结局

Decrease in FEV1

时间窗: up to 6 days after surgery

Postoperative loss of FEV1 in percent of absolute preoperative levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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